Astellas files combination urology product EC905 in Europe

Netherlands filing to treat symptoms of benign prostatic hyperplasia paves way for rest of Europe

Astellas Pharma has filed for approval of a new drug to treat the symptoms of benign prostatic hyperplasia (BPH) in the Netherlands, starting the process for EU-wide registration.

The new product, called EC905, is a fixed-dose combination of solifenacin and tamsulosin and has been filed with a proposed indication of treating lower urinary tract symptoms (LUTS) associated with BPH.

To date BPH patients have often had to take a combination of different products to manage their symptoms effectively, and EC905 aims to reduce pill burden and maintain efficacy and tolerability.

The Dutch filing is based on the results of the phase III NEPTUNE study, which were presented at the end of February at the European Association of Urology congress in Paris.

In that study, EC905 improved LUTS in men aged over 45 with both voiding and storage symptoms, performing better than both placebo and tamsulosin monotherapy.

LUTS are common in men and include symptoms of voiding, including hesitancy and intermittency, as well as storage symptoms (frequency, urgency, nocturia) and feelings of incomplete bladder emptying.

In a study of four European countries plus Canada, LUTS was found to affect more than 60 per cent of the adult male population.

Astellas has made urology one of its main therapeutic franchises, and has previously said it aims to achieve sales of 170bn yen ($2bn) in this category in fiscal 2014.

EC905 is one of the foundations of that strategy in Europe, extending Astellas' Harnal and Vesicare monotherapy products, which achieved sales of 66.5bn yen ($800m) and 86.7bn yen ($1bn), respectively, in fiscal 2010.